The European Pharmacopoeia (Ph. Eur.) at the European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking feedback on its new general text on the comparability of alternative analytical procedures (5.27).
The draft text elaborates on the requirement expressed more succinctly in the Ph. Eur. General Notices, according to which a user may – with the agreement of the competent authority – use alternative analytical procedures for control purposes provided that they enable an unequivocal decision to be made with regard to compliance with the standards of the monographs if the official procedures were used.
Once adopted by the Ph. Eur. Commission, this new general text will represent a major addition to the Ph. Eur. as it provides more detailed information on one of the processes that offers users greater flexibility in their demonstration of compliance with the Ph. Eur. monographs. It is also expected to prove valuable both to users who choose to employ alternative analytical procedures and to assessors during evaluation. However, when considering this approach, users should bear in mind that for cases where the specification described in a monograph is considered insufficient to ensure the quality of the article by a competent authority (see section 220.127.116.11 of the General Notices, version of Supplement 10.7), any additional test employed is not an “alternative procedure”.
The new general text is published in Pharmeuropa 34.2 for public consultation from April until the end of June 2022. The EDQM invites all interested parties to review the draft and submit their comments. For more information on how to comment, please consult our guide.